Two similarly-designed, randomized, double-blind, placebo-controlled studies were conducted in a total of 970 adult patients with active, mild to moderate ulcerative colitis (UC) which was defined as an Ulcerative Colitis Disease Activity Index (UCDAI of ≥ 4 and ≤ 10). Eight-hundred ninety-nine of these patients had histology consistent with active UC; this was considered the primary analysis population. UCDAI is a four-component scale (total score of 0 to 12) that encompasses the clinical assessments of stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity (score of 0 to 3 for each of the components).
Gabapentin is available as capsules as 100, 300, and 400 mg; tablets as 100, 300, 400, 600, and 800 mg; and as a solution of 250 mg/5 ml. The exact dosage depends upon the condition being treated. It is not known if this drug is safe to take during pregnancy . It is secreted in breast milk, so mothers who are breastfeeding should consult their OB/GYN or other health care professional and only use this gabapentin if the benefits outweigh the risks to the fetus. Gabapentin is not a narcotic (opioid), however, it does share signs and symptoms associated with drug abuse and addiction . Patients taking this drug may experience withdrawal symptoms like goosebumps, sweating , vomiting , and nausea . Gabapentin was approved by the FDA in 1993.